NCT02857478

Brief Summary

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

1 day

First QC Date

August 3, 2016

Last Update Submit

December 11, 2018

Conditions

Sunscreen Agents

Outcome Measures

Primary Outcomes (2)

  • Evaluation of Erythema as graded on a 5 point scale.

    approximately 24 hours

  • Evaluation of AEs, including eye stinging

    Reported as product related or likely product related by the investigator or trained designee

    approximately 24 hours

Study Arms (1)

Safety of a Sunscreen product

EXPERIMENTAL

Sunscreen product safety evaluation under supervised out-door conditions on sport users.

Drug: BAY 987519, SPF 50, Y51-002Drug: BAY 987519, SPF 50, P04-147

Interventions

BAY 987519, SPF 50, Y51-002DRUG

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

Safety of a Sunscreen product
BAY 987519, SPF 50, P04-147DRUG

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

Safety of a Sunscreen product

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, aged 18 to 65 years
  • No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
  • Must not have visible erythema, blistering or peeling that would indicate recent sunburn
  • Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
  • Must not be taking any medication in which exposure to the sun is contraindicated
  • Must be willing to obey all rules of the test facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 5, 2016

Study Start

June 27, 2015

Primary Completion

June 28, 2015

Study Completion

June 28, 2015

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

US(1)